With a serious decline in only 1 in 10 drugs successfully passing phase II/III of clinical trials, there is increasing pressure to bring drugs quickly into the market and reduce the cost of drug development. This conference offers the perfect platform to hear strategies such as “Seamless Adaptive Designs” and “Group –Sequential Adaptive Designs” which are areas that improve the efficiency of drug development. This conference will review the drug development process and provide a detailed discussion of how adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial. It is designed for those looking to network and gain the latest knowledge from the academics, industry leaders and regulators.>>>>Key Presentation Highlights include: • Understand the objectives of Adaptive Licensing and MAPPs as the “breakthrough” designations to accelerate the approval of new medicines.• Learn how Bayesian Belief Networks can support reliability management and decision making.• Discover novel techniques in CARA and Seamless Adaptive Designs and Bayesian Bandit models to optimize efficiency in dosefinding strategies.• Benefit from the talks of industry leaders and CEO’s in clinical leadership and how real world evidence can improve adaptive>>>>>Our Speaker Line Up Includes:• Dr. Graham Clarke, Senior Director and Head of Respiratory & Inflammation Early Clinical Development, Quintiles• Robert Clay, Consultant, Highbury Regulatory Science, Chief Regulatory Officer, Kinapse; Board Director, TOPRA• Professor Emeritus Tamás L. Paál, Faculty of Pharmacy, Institute of Drug Regulatory Affairs, University of Szeged, Hungary and Regulatory Adviser, Hungarian Medicines Agency• Dr. Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd.• Loïc Darchy, Head of Statistical Methodology Group,Sanofi R&D• Han-Joo Kim, PhD, Associate Director, Biostatistics, Oncology PCU, Eisai IncPLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPSPLUS TWO POST CONFERENCE INTERACTIVE WORKSHOP(AM) Bayesian Adaptive Clinical Designs and StrategiesWorkshop Leader: Dr. Sophie Carr, MD and Principal Analyst,Bays Consulting Ltd (PM) Winning with Adaptive Trial Strategies and Clinical Compliance across the Evolving International Regulatory LandscapeWorkshop Leader: Robert Clay, Consultant, Highbury RegulatoryScience, Chief Regulatory Officer, Kinapse, Board Director, TOPRA
When
20 Apr 2015 @ 09:00 am
21 Apr 2015 @ 09:00 am
Duration: 1 days
Where
Marriott Regents Park Hotel
128 King Henry's Road
United Kingdom
Language
English en
Organised by
SMi Group Ltd. Event published: 25 Nov 2014
Event last updated: 18 Jul 2016